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The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.

Current status:

Marketed

Current status date:

2017-09-05

Original market date: See footnote 1

2014-06-11

Product name:

HYDROMORPHONE HYDROCHLORIDE INJECTION USP

Description:

1/5/50ML SINGLE USE VIALS

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section .

DIN:

02382636

Product Monograph/Veterinary Labelling:

Date: 2018-08-24 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

PFIZER CANADA ULC
17300 Trans-Canada Highway
Kirkland
Quebec
Canada  H9J 2M5

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Subcutaneous,  Intramuscular,  Intravenous

Number of active ingredient(s):

1

Schedule(s):

Narcotic (CDSA I)  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

28:08.08   OPIATE AGONISTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

N02AA03  HYDROMORPHONE

Active ingredient group (AIG) number:See footnote 5

0108698001

List of active ingredient(s)
Active ingredient(s) Strength
HYDROMORPHONE HYDROCHLORIDE 10 MG / ML

Risk Management Plans See footnote 7

A Canadian Specific Opioid targeted Risk Management Plan (CSO-tRMP) for this product was submitted.

Additional Risk Minimization Measures
Controlled Distribution Program
Healthcare Professional Education

Application information

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